510(k) K251395

The Rialto™ SI Fusion System by Medtronic Sofamor Danek USA, Inc. — Product Code OUR

K251395 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek USA, Inc. for the device "The Rialto™ SI Fusion System". The FDA issued a decision of Substantially Equivalent on June 26, 2025. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Medtronic Sofamor Danek USA, Inc. has at least 10 other 510(k) clearances on record.